IRBESARTAN/HYDROCHLOROTHIAZIDE KERN PHARMA 300 mg/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Irbesartan/Hydrochlorothiazide Kern Pharma 300 mg/12.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Irbesartan/Hydrochlorothiazide Kern Pharma and what is it used for
2. What you need to know before you take Irbesartan/Hydrochlorothiazide Kern Pharma
3. How to take Irbesartan/Hydrochlorothiazide Kern Pharma
4. Possible side effects
5. Storage of Irbesartan/Hydrochlorothiazide Kern Pharma
6. Contents of the pack and other information

1. What is Irbesartan/Hydrochlorothiazide Kern Pharma and what is it used for

Irbesartan/Hydrochlorothiazide Kern Pharma is a combination of two active substances, irbesartan and hydrochlorothiazide.

Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists.

Angiotensin-II is a substance produced in the body that binds to blood vessel receptors, causing them to constrict. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, relaxing blood vessels and reducing blood pressure.

Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase the amount of urine excreted, reducing blood pressure.

The two active substances in Irbesartan/Hydrochlorothiazide Kern Pharma work together to achieve a greater reduction in blood pressure than either substance alone.

Irbesartan/Hydrochlorothiazide Kern Pharma is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone does not provide adequate control of blood pressure.

2. What you need to know before you take Irbesartan/Hydrochlorothiazide Kern Pharma

Do not takeIrbesartan/Hydrochlorothiazide Kern Pharma

• if you are allergic(hypersensitive) to irbesartan or any of the other ingredients of Irbesartan/Hydrochlorothiazide Kern Pharma.
• if you are allergic(hypersensitive) to hydrochlorothiazide or any other sulfonamide-derived medication.
• if you are pregnant for more than 3 months. (In any case, it is best to avoid taking this medication during the start of pregnancy – see section Pregnancy).
• if you have severe liver or kidney problems.
• if you have difficulty urinating.
• if your doctor detects that you have persistently elevated calcium levels or low potassium levels in your blood.
• if you have diabetes or kidney failure and are being treated with a blood pressure medication containing aliskiren.

Irbesartan/Hydrochlorothiazide Kern Pharma should not be given to children and adolescents (under 18 years of age).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Irbesartan/Hydrochlorothiazide Kern Pharma.

Tell your doctorin any of the following cases:

• if you have excessive vomiting or diarrhea.
• if you have kidney problemsor if you have had a kidney transplant.
• if you have heart problems.
• if you have liver problems.
• if you have diabetes.
• if you have systemic lupus erythematosus(also known as lupus or SLE).
• if you have primary aldosteronism(a condition related to excessive production of the hormone aldosterone, leading to sodium retention and increased blood pressure).
• if you are taking any of the following medications used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have diabetes-related kidney problems.
• aliskiren.
• if you have had skin canceror if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Irbesartan/Hydrochlorothiazide Kern Pharma.
• If you experience blurred vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, and can occur within hours to a week after taking Irbesartan/Hydrochlorothiazide Kern Pharma.
• If you have had respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience severe shortness of breath or difficulty breathing after taking Irbesartan/Hydrochlorothiazide Kern Pharma, seek medical attention immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Irbesartan/Hydrochlorothiazide Kern Pharma”.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Irbesartan/Hydrochlorothiazide Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Irbesartan/Hydrochlorothiazide Kern Pharma on your own.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended during the first trimester of pregnancy (first 3 months), and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

You should also inform your doctor:

• if you are on a low-salt diet.
• if you experience any of the following symptoms: feeling thirsty, dry mouth, weakness, feeling sleepy, muscle pain or cramps, nausea, vomiting, or rapid heartbeat, as these may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan/Hydrochlorothiazide Kern Pharma).
• if you experience to the sun with symptoms of sunburn (such as redness, itching, swelling, blisters) that occurs more quickly than usual.
• if you are going to have surgery(surgical procedure) or if you are going to be given anesthetics.

Hydrochlorothiazide in this medication may cause positive results in doping tests.

Using Irbesartan/Hydrochlorothiazide Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Diuretics, such as hydrochlorothiazide in Irbesartan/Hydrochlorothiazide Kern Pharma, may interact with other medicines. You should not take Irbesartan/Hydrochlorothiazide Kern Pharma with medications containing lithium without your doctor's supervision.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Irbesartan/Hydrochlorothiazide Kern Pharma” and “Warnings and precautions”).

You may need to have blood tests if you take:

• potassium supplements.
• salt substitutes that contain potassium.
• potassium-sparing medications or other diuretics (pills that increase urine production).
• certain laxatives.
• medications used to treat gout.
• vitamin D supplements.
• medications to control heart rhythm.
• medications for diabetes (oral agents or insulins).

It is also important to inform your doctor if you are taking other blood pressure medications, steroids, cancer treatments, pain relievers, arthritis medications, or cholestyramine or colestipol resins to lower cholesterol in the blood.

Taking Irbesartan/Hydrochlorothiazide Kern Pharma with food and drinks

Irbesartan/Hydrochlorothiazide Kern Pharma can be taken with or without food.

Due to the hydrochlorothiazide in Irbesartan/Hydrochlorothiazide Kern Pharma, if you drink alcohol while taking this medication, you may experience increased dizziness when standing up, especially when getting up from a seated position.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Irbesartan/Hydrochlorothiazide Kern Pharma before you become pregnant or as soon as you find out you are pregnant, and will recommend an alternative blood pressure medication. Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended during the first trimester of pregnancy (first 3 months), and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as Irbesartan/Hydrochlorothiazide Kern Pharma is not recommended for use during breastfeeding. Your doctor may decide to prescribe a more suitable treatment if you wish to breastfeed, especially for newborns or premature babies.

Driving and using machines

No studies have been performed on the ability to drive and use machines. It is unlikely that Irbesartan/Hydrochlorothiazide Kern Pharma will affect your ability to drive or use machines. However, during hypertension treatment, dizziness or fatigue may occasionally occur. If you experience these symptoms, talk to your doctor before driving or using machines.

Important information about some of the ingredients of Irbesartan/Hydrochlorothiazide Kern Pharma

Irbesartan/Hydrochlorothiazide Kern Pharma contains lactose. If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult your doctor before taking this medication.

3. How to take Irbesartan/Hydrochlorothiazide Kern Pharma

Follow the instructions for administration of Irbesartan/Hydrochlorothiazide Kern Pharma exactly as prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Dose

The normal dose of Irbesartan/Hydrochlorothiazide Kern Pharma is one tablet per day. In general, your doctor will prescribe Irbesartan/Hydrochlorothiazide Kern Pharma when previous treatments have not sufficiently reduced your blood pressure. Your doctor will advise you on how to switch from previous treatments to Irbesartan/Hydrochlorothiazide Kern Pharma.

Method of administration

Irbesartan/Hydrochlorothiazide Kern Pharma is administered orally. The tablets should be swallowed with a sufficient amount of liquid (e.g., a glass of water). You can take Irbesartan/Hydrochlorothiazide Kern Pharma with or without food. Try to take your daily dose at the same time each day. It is important that you continue taking Irbesartan/Hydrochlorothiazide Kern Pharma until your doctor advises you to stop.

The maximum blood pressure-reducing effect should be achieved within 6-8 weeks after starting treatment.

If you take more Irbesartan/Hydrochlorothiazide Kern Pharma than you should

In case of overdose or accidental ingestion, go to a Medical Center or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the leaflet of the medication.

Children should not take Irbesartan/Hydrochlorothiazide Kern Pharma

Irbesartan/Hydrochlorothiazide Kern Pharma should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you forget to take Irbesartan/Hydrochlorothiazide Kern Pharma

If you accidentally miss a dose, simply take your normal dose when it is due next. Do not take a double dose to make up for missed doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Irbesartan/Hydrochlorothiazide Kern Pharma can cause adverse effects, although not all people suffer from them.

Some of these effects can be serious and may require medical attention.

Rarely, cases of allergic skin reactions (skin rash, urticaria) have been reported in patients treated with irbesartan, as well as localized inflammation in the face, lips, and/or tongue. If you have any of the above symptoms or experience shortness of breath, stop taking Irbesartan/Hydrochlorothiazide Kern Pharma and contact your doctor immediately.

The adverse effects reported in clinical studies for patients treated with Irbesartan/Hydrochlorothiazide Kern Pharma were:

Frequent Adverse Effects(affecting between 1 and 10 out of 100 patients):

• nausea/vomiting
• urination anomalies
• fatigue
• dizziness (including that which occurs when standing up from a lying or sitting position)
• blood tests may show elevated levels of an enzyme that measures muscle and heart function (creatine kinase) or elevated levels of substances that measure kidney function (urea nitrogen in the blood, creatinine).

If any of these adverse effects cause you problems, consult your doctor.

Infrequent Adverse Effects(affecting between 1 and 10 out of 1000 patients):

• diarrhea
• low blood pressure
• fainting
• tachycardia
• flushing
• fluid retention swelling (edema)
• sexual dysfunction (sexual function disorders)
• blood tests may show low levels of sodium and potassium in your blood.

If any of these adverse effects cause you problems, consult your doctor.

Adverse Effects Since the Marketing of Irbesartan/Hydrochlorothiazide

The frequency of occurrence of these effects is unknown. These adverse effects are: headache, ringing in the ears, cough, taste disturbance, indigestion, joint and muscle pain, liver function disorders and kidney failure, high levels of potassium in your blood, and allergic reactions such as skin rash, urticaria, swelling of the face, lips, mouth, tongue, or throat.

Rare Adverse Effects(affecting less than 1 in 1000 patients)

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

As with all combinations of two active principles, the adverse effects associated with each component cannot be excluded.

Adverse Effects Associated Only with Irbesartan

Rare Adverse Effects(affecting less than 1 in 1000 patients)

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

In addition to the adverse effects described above, chest pain and a reduction in the number of platelets have also been observed.

Adverse Effects Associated with Hydrochlorothiazide in Monotherapy

Lack of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); pancreatitis characterized by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma]; lack of white blood cells, which can lead to frequent infections, fever; decreased platelet count (blood cells essential for blood coagulation), decreased red blood cell count (anemia) characterized by fatigue, headaches, shortness of breath when exercising, dizziness, and paleness; kidney disease; pulmonary disorders including pneumonia or fluid accumulation in the lungs; increased skin sensitivity to the sun; inflammation of blood vessels; a skin disease characterized by peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that can appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasms; alteration of heart rhythm; reduction of blood pressure after a change in body position; swelling of the salivary glands; high blood sugar levels; sugar in the urine; increases in some types of blood fats; high levels of uric acid in the blood, which can cause gout, skin and lip cancer (non-melanoma skin cancer), acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

It is known that the adverse effects associated with hydrochlorothiazide can increase with higher doses of hydrochlorothiazide.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Irbesartan/Hydrochlorothiazide Kern Pharma

Keep this medicine out of sight and reach of children.

Do not use Irbesartan/Hydrochlorothiazide Kern Pharma after the expiration date that appears on the carton and on the blister after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Keep in the original packaging to protect it from light.

Medicines should not be thrown away through the sewers or in the trash. Deposit the containers and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Content of the Prospectus and Additional Information

Composition of Irbesartan/Hydrochlorothiazide Kern Pharma

• The active ingredients are irbesartan and hydrochlorothiazide. Each film-coated tablet of Irbesartan/Hydrochlorothiazide Kern Pharma 300 mg/12.5 mg contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.

• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, povidone, and sodium fumarate, hypromellose, titanium dioxide, macrogol, red and yellow iron oxides.

Appearance of the Product and Packaging Content

The film-coated tablets of Irbesartan/Hydrochlorothiazide Kern Pharma 300/12.5 mg are pink, round, and have a unilateral score.

Irbesartan/Hydrochlorothiazide Kern Pharma 300/12.5 mg is available in blister packs with 28 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Prospectus: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/